This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
København Ø, Denmark
Unnamed facility
Amsterdam, Netherlands
Safety: Incidence of adverse events
Time frame: approximately 2 years
Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0
Time frame: approximately 2 years
Maximum Tolerated Dose (MTD)
Time frame: approximately 2 years
Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules
Time frame: approximately 2 years
Tumor response according to RECIST criteria
Time frame: approximately 2 years
Antigenicity: Human anti-human antibody [HAHA] profile
Time frame: approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.